Length-based adequacy thresholds for submandibular gland core needle biopsy in suspected Sjögren's disease: two-phase study.
Journal
Clinical and experimental rheumatology
Journal Volume
43
Journal Issue
12
Pages
2188 - 2196
ISSN
0392-856X
Date Issued
2025-12
Author(s)
Cheng, Chiao-Feng
Chen, Tseng-Cheng
Hsieh, Min-Shu
Huang, Chung-Yen
Kao, Jui-Hung
Lan, Ting-Yuan
Lin, Yu-Heng
Wang, Chi
Huang, Hsien-Neng
Lin, Long-Wei
Chiang, Yu-Ju
Cheng, Mei-Fang
Chu, Hsiao-Sang
Lu, Cheng-Hsun
Li, Ko-Jen
Hsieh, Song-Chou
Abstract
Ultrasound-guided core needle biopsy (CNB) of major salivary glands is a less invasive alternative to minor salivary gland biopsy for diagnosing Sjögren's disease (SjD), reducing risks of neurological deficits and pain. However, the optimal CNB specimen length for adequate glandular surface area remains uncertain. This study aimed to determine and validate the optimal CNB specimen length thresholds.
This retrospective, dual-phase study included 119 consecutive patients undergoing submandibular gland CNB with an 18-gauge needle for suspicious chronic inflammatory sialadenitis. Specimen length, total surface area, and glandular surface area were recorded. A validation cohort (n=37) was analysed separately. Statistical analyses included correlation, regression, and ROC curve analysis.
Specimen length correlated with glandular surface area (ρ=0.69, p<0.001). Multivariable analysis confirmed specimen length as a positive predictor (p<0.001) and fatty infiltration as a negative predictor (p=0.003) of glandular surface area. ROC analysis identified 7.6 mm as optimal for glandular surface area ≥4 mm², and 10.5 mm for ≥8 mm². Clinically significant haematomas occurred in 1.7% of cases. In the validation cohort, using the 7.6 mm threshold, PPV was 86.2%, and NPV 87.5% for glandular surface area ≥4 mm². For the 10.5 mm threshold, PPV was 76%, and NPV 100% for ≥8 mm².
A CNB specimen length of ≥7.6 mm is sufficient for diagnosing SjD, while ≥10.5 mm may be required for clinical trials. These findings may support the integration of specimen length thresholds into CNB procedural guidelines.
Type
journal article